Commission Regulation (EC) No 1916/98 of 9 September 1998 amending Annexes I and II to Council Regulation (EEC) No 2377/90 laying down a Community procedure for the establishment of maximum residue limits of veterinary medicinal products in foodstuffs of animal origin (Text with EEA relevance)
Date: 1998-09-09
Institutions: European Commission
Subjects: animal product, food inspection, veterinary drug, waste

L 250/8

EN

Official Journal of the European Communities

10. 9. 98

COMMISSION REGULATION (EC) No 1916/98

of 9 September 1998

amending Annexes I and II to Council Regulation (EEC) No 2377/90 laying down
a Community procedure for the establishment of maximum residue limits of
veterinary medicinal products in foodstuffs of animal origin

(Text with EEA relevance)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

honey bees, maximum residue limits must also be estab-
lished for eggs, milk or honey;

Having regard to the Treaty establishing the European
Community,

Whereas toltrazuril and amitraz should be inserted into
Annex I to Regulation (EEC) No 2377/90;

Having regard to Council Regulation (EEC) No 2377/90
of 26 June 1990 laying down a Community procedure for
the establishment of maximum residue limits of veter-
inary medicinal products in foodstuffs of animal origin (1),
as last amended by Commission Regulation (EC) No
1570/98 (2), and in particular Articles 6 and 8 thereof,

Whereas, in accordance with Regulation (EEC) No 2377/
90, maximum residue limits must be established progres-
sively for all pharmacologically active substances which
are used within the Community in veterinary medicinal
products intended for administration to food-producing
animals;

Whereas maximum residue limits should be established
only after the examination within the Committee for
Veterinary Medicinal Products of all the relevant informa-
tion concerning the safety of residues of the substance
concerned for the consumer of foodstuffs of animal origin
and the impact of residues on the industrial processing of
foodstuffs;

Whereas, in establishing maximum residue limits for resi-
dues of veterinary medicinal products in foodstuffs of
animal origin, it is necessary to specify the animal species
in which residues may be present, the levels which may
be present in each of the relevant meat tissues obtained
from the treated animal (target tissue) and the nature of
the residue which is relevant for the monitoring of resi-
dues (marker residue);

Whereas, for the control of residues, as provided for in
appropriate Community legislation, maximum residue
limits should usually be established for the target tissues
of liver or kidney; whereas, however, the liver and kidney
are frequently removed from carcases moving in inter-
national trade, and maximum residue limits should there-
fore also always be established for muscle or fat tissues;

clazuril,

aluminium distearate,

Whereas
aluminium
hydroxide acetate, aluminium phosphate, aluminium tris-
tearate, ammonium chloride, cobalt carbonate, cobalt
dichloride, cobalt gluconate, cobalt oxide, cobalt sulphate,
cobalt trioxide, iron sulphate, terebinthinae laricina, coco
alkyl dimethyl betaines, diprophylline, hexetidine, poly-
ethylene glycol 15 hydroxystearate, polyethylene glycol 7
glyceryl cocoate, polyethylene glycol stearates with 8-40
oxyethylene units, prethcamide (crotethamide, cropropa-
mide), terpin hydrate, balsamum peruvianum, oxidation
products of terebinthinae oleum, ricini oleum and tere-
binthinae aetheroleum rectificatum and iron dichloride
should be inserted into Annex II to Regulation (EEC) No
2377/90;

Whereas a period of 60 days should be allowed before the
this Regulation in order to allow
entry into force of
Member States to make any adjustment which may be
necessary to the authorisations to place the veterinary
medicinal products concerned on the market which have
been granted in accordance with Council Directive 81/
851/EEC (3), as last amended by Directive 93/40/EEC (4),
to take account of the provisions of this Regulation;

Whereas the measures provided for in this Regulation are
the Standing
in accordance with the opinion of
Committee on Veterinary Medicinal Products,

HAS ADOPTED THIS REGULATION:

Article 1

Annexes I and II to Regulation (EEC) No 2377/90 are
hereby amended as set out in the Annex hereto.

Article 2

Whereas, in the case of veterinary medicinal products
lactating animals or
intended for use in laying birds,

This Regulation shall enter into force on the 60th day
following its publication in the Official Journal of the
European Communities.

(1) OJ L 224, 18. 8. 1990, p. 1.
(2) OJ L 205, 22. 7. 1998, p. 10.

(3) OJ L 317, 6. 11. 1981, p. 1.
(4) OJ L 214, 24. 8. 1993, p. 31.

10. 9. 98

EN

Official Journal of the European Communities

L 250/9

This Regulation shall be binding in its entirety and directly applicable in all Member
States.

Done at Brussels, 9 September 1998.

For the Commission

Martin BANGEMANN

Member of the Commission

L 250/10

EN

Official Journal of the European Communities

10. 9. 98

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c
i
p
o
t

r
o
F

e
n

i
r
p
a
c

,

e
n

i
v
o

,

e
n

i
c
r
o
p

,

e
n

i
v
o
B

m
u
e
l
o

e
a
n
i
h
t
n
i
b
e
r
e
t

f
o

s
t
c
u
d
o
r
p

n
o
i
t
a
d
i
x
O

s
e
i
c
e
p
s

g
n
i
c
u
d
o
r
p

d
o
o
f

l
l

A

m
u
e
l
o

i
n
i
c
i

R

s
e
i
c
e
p
s

g
n
i
c
u
d
o
r
p

d
o
o
f

l
l

A

m
u
t
a
c
i
f
i
t
c
e
r

m
u
e
l
o
r
e
h
t
e
a

e
a
n
i
h
t
n
i
b
e
r
e
T

s
e
i
c
e
p
s

g
n
i
c
u
d
o
r
p

d
o
o
f

l
l

A

a
n
i
c
i
r
a
l

e
a
n
i
h
t
n
i
b
e
r
e
T

n
i
g
i
r
o

e
l
b
a
t
e
g
e
v

f
o

s
e
c
n
a
t
s
b
u
S

.

6